Aldeyra's Reproxalap Hits Primary Goals In Dry Eye Disease Chamber Crossover Trial

Aldeyra Therapeutics Inc ALDX achieved the primary endpoints in a crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for dry eye disease.
Relative to the vehicle, a statistically significant reduction in ocular redness was observed following treatment with reproxalap as soon as 10 minutes after dry eye chamber entry.
The Schirmer test, assessed approximately 10 minutes before and after the fourth dose of reproxalap or vehicle, was statistically significant in favor of reproxalap at both time points.
Also Read: Why Aldeyra Therapeutics' Shares Are Soaring Today?
No safety signals were observed in the trial, and reproxalap was well tolerated; there were no treatment-emergent moderate or serious adverse events.
Three patients were discontinued due to adverse events, two during vehicle administration and one during reproxalap administration. Reproxalap has now been studied in over 1,800 patients.
A pre-NDA meeting with the FDA has been scheduled for Q3 of 2022.
Price Action: ALDX shares are up 6.26% at $4.75 during the premarket session on the last check Tuesday.